FDA.reportPublic FDA data

APTUS

Primary DI
07630894802461
Brand
APTUS
Company
Medartis AG
Model
A-4950.27TP
Catalog number
A-4950.27TP
Device description
Template for A-4950.27S
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230971000APTUS® 3.5 TriLock Straight PlatesMedartis AG2023-06-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894802461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894802461076308948024617630894802461

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894827723AVENGERM07S0011M07S00112026-10-13
07630894827730AVENGERM07S002AM07S002A2026-10-13
07630894827747AVENGERM07S002BM07S002B2026-10-13
07630008400613APTUSA-2047A-20472026-07-16
07630008405793APTUSA-6095.05A-6095.052026-07-16
07630008405809APTUSA-6095.06A-6095.062026-07-16
07630008405878APTUSA-6095.13A-6095.132026-07-16
07630008405892APTUSA-6095.15A-6095.152026-07-16
07630008406226APTUSA-6095.61A-6095.612026-07-16
07630008406233APTUSA-6095.62A-6095.622026-07-16
07630008406240APTUSA-6095.63A-6095.632026-07-16
07630008406257APTUSA-6095.64A-6095.642026-07-16
07630008406264APTUSA-6095.65A-6095.652026-07-16
07630008406271APTUSA-6095.66A-6095.662026-07-16
07630008406288APTUSA-6095.67A-6095.672026-07-16
07630008406295APTUSA-6095.70A-6095.702026-07-16
07630008406301APTUSA-6095.71A-6095.712026-07-16
07630008406318APTUSA-6095.72A-6095.722026-07-16
07630008406325APTUSA-6095.73A-6095.732026-07-16
07630008406332APTUSA-6095.74A-6095.742026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810136433593OptimalMTP®Forma Medical, Inc.HRS2026-10-16
00810136433609OptimalMTP®Forma Medical, Inc.HRS2026-10-16
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08809986482815CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482822CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482839CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482853CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482761CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06